FDAClass IINovember 20, 2013

Biotene Moisturizing Mouth Spray recall

Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol…

Why was Biotene Moisturizing Mouth Spray recalled?

Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.

Product
Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol…
Recalling firm
GlaxoSmithKline, LLC.
Quantity
483,204 bottles
Distribution
Nationwide Distribution .
Recall date
November 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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